Legal claims defining the scope of protection, as filed with the USPTO.
1. An instrumented nipple for monitoring oral motor kinetics in an infant comprising: an instrumented nipple comprising a first pressure transducer and a second pressure transducer for detecting pressure pulses when the nipple is placed in the mouth of an infant; and a processor in operational communication with the first pressure transducer and the second pressure transducer of the nipple for processing signals from the first pressure transducer and the second pressure transducer to provide information about the infant's oral motor kinetics when the nipple is in the infant's mouth; wherein the first and second pressure transducers are mounted on a same outside surface of the nipple, and are spaced apart from each other by a distance L 0 along the nipple's long axis; and wherein the first pressure transducer and the second pressure transducer are located within one or more flexible tubes positioned at least partially on the exterior of a neck of the nipple.
2. The system of claim 1 wherein the first pressure transducer and second pressure transducer measure the positive pressures exerted by an Expression component of sucking when the infant's tongue compresses and/or strips the nipple against an infant's hard palate.
3. The system of claim 1 wherein the second pressure transducer is located closer to a base of the nipple as compared to the position of the first pressure transducer which is located closer to a tip of the nipple as compared to the position of the second pressure transducer.
4. The system of claim 1 wherein the distance L 0 , between the first pressure transducer and the second pressure transducer is between about 0.1-3 cm along the long axis of the nipple.
5. The system of claim 1 wherein the nipple is selected from the group consisting of a nipple shield, a finger of a glove, a pacifier, and a nipple of a feeding bottle.
6. The system of claim 1 wherein the processing by the processor is selected from the group consisting of receiving, storing, displaying, analyzing and transmitting.
7. An instrumented nipple comprising: a first pressure transducer and a second pressure transducer associated with the instrumented nipple for detecting pressure pulses when the instrumented nipple is placed in the mouth of an infant; wherein the first and second pressure transducers are mounted on a same outside surface of the nipple, and are spaced apart from each other by a distance L 0 along the nipple's long axis; and wherein the first and second pressure transducers are located within one or more flexible tubes positioned at least partially on the exterior of a neck of the nipple.
8. The instrumented nipple of claim 7 wherein the nipple is selected from the group consisting of a nipple shield, a finger of a glove, a pacifier, and a nipple of a feeding bottle.
9. The instrumented nipple of claim 7 wherein the first and second pressure transducers are located within one or more flexible tubes positioned at least partially on the exterior of a neck of the nipple.
10. The instrumented nipple of claim 7 wherein the distance L 0 , between the first pressure transducer and the second pressure transducer is between about 0.1-3 cm along the long axis of the nipple.
11. A method for evaluating an infant's oral motor kinetics comprising: a) inserting an instrumented nipple into a mouth of an infant; wherein the instrumented nipple comprises a nipple comprising a first pressure transducer and a second pressure transducer for detecting pressure pulses when the nipple is placed in the mouth of the infant; and wherein the first and second pressure transducers are mounted on a same outside surface of the nipple, and are spaced apart from each other by a distance L 0 along the nipple's long axis; and wherein the first pressure transducer and the second pressure transducer are located within one or more flexible tubes positioned at least partially on the exterior of a neck of the nipple; b)activating the first and second pressure transducers of the instrumented nipple with pressure provided by the infant's tongue pressing against the nipple; and c) analyzing temporal signals received from activation of the first and second pressure transducers to determine the oral motor kinetics of the infant during sucking; and d) processing with a processor in operational communication with the first pressure transducer and the second pressure transducer signals from the first pressure transducer and the second pressure pressure transducer to provide information about the infant's oral motor kinetics.
12. The method of claim 11 wherein analyzing the signals includes measuring over time a temporal sequence of pressure pulses generated at the first and second pressure transducers; and determining if a mode of Expression comprises Compression or Stripping.
13. The method of claim 11 wherein the instrumented nipple comprises a finger glove or a pacifier.
14. The method of claim 11 wherein the instrumented nipple comprises a nipple attached to a feeding bottle; and the method further comprises delivering fluid from the bottle to the infant through said instrumented nipple when the infant is feeding.
15. The method of claim 11 further comprising monitoring an amount of fluid delivered to the infant from the nipple during oral feeding.
16. A method for evaluating an infant's oral motor kinetics comprising: a) inserting an instrumented nipple into a mouth of an infant; wherein the instrumented nipple comprises: a nipple comprising a first pressure transducer and a second pressure transducer for detecting pressure pulses when the nipple is placed in the mouth of the infant, wherein the first and second pressure transducers are mounted on a same outside surface of the nipple, and are spaced apart from each other by a distance L 0 along the nipple's long axis; and wherein the second pressure transducer is located closer to a base of the nipple as compared to a position of the first pressure transducer, which is located closer to a tip of the nipple as compared to a position of the second pressure transducer; b) activating the first and second pressure transducers of the instrumented nipple with pressure provided by the infant's tongue pressing against the nipple; and c) analyzing temporal signals received from activation of the first and second pressure transducers to determine the oral motor kinetics of the infant during sucking; and d) processing with a processor in operational communication with the first pressure transducer and the second pressure transducer signals from the first pressure transducer and the second pressure transducer to provide information about the infant's oral motor kinetics; wherein analyzing the signals includes measuring over time a temporal sequence of pressure pulses generated at the first and second pressure transducers; and determining if a mode of Expression comprises Compression or Stripping; and further comprising analyzing the Expression component of sucking with the instrumented nipple to identify compression and/or stripping signals by comparing the temporal synchrony of peak (maximum) pressure pulses measured by the first pressure transducer (PT 1 =PT tip ) and the second pressure transducer (PT 2 =PT base ) according to the following algorithm: Step 1: determine a tpeak/tip at which the peak pressure occurs for the first pressure transducer at the tip; Step 2: determine a time, tpeak/base at which the peak pressure occurs for the second pressure transducer at the base, during Step 1; Step 3: compare t tip peak to t base peak ; Step 4: if t base peak <t tip peak then identify the expression mode as “Stripping”; and Step 5: if t tip peak ≅t base peak then identify the expression mode as “Compression Only”; Step 6: if t tip peak >t base peak then identify the expression mode as “No Clear Mode of Expression Identified”.
17. The method of claim 16 further comprising monitoring a clinical parameter selected from the group consisting of heart rate, oxygen saturation, respiration, and esophageal activity, and combinations thereof.
18. The method of claim 16 , wherein the nipple further comprises a third pressure transducer mounted flush with the nipple wall and located near the distal tip of the nipple; and wherein the method further comprises measuring an intraoral pressure outside of the nipple with the third pressure transducer.
19. The method of claim 16 , wherein the first pressure transducer and the second pressure transducer are located within one or more flexible tubes positioned at least partially on the exterior of a neck of the nipple.
20. The method of claim 16 , wherein the distance L 0 , between the first pressure transducer and the second pressure transducer is between about 0.1-3cm along the long axis of the nipple.
21. The method of claim 16 , wherein the nipple is selected from the group consisting of a nipple shield, a finger of a glove, a pacifier, and a nipple of a feeding bottle.
22. The method of claim 16 , wherein the operational communication of the processor to the pressure transducers is wireless.
23. The method of claim 16 further comprising measuring one or more characteristics of sucking selected from the group consisting of: duration of the sucking action, peak amplitude of the Suction and Expression components of the sucking action, duration of the individual Suction and Expression components of sucking, and number of Suction and Expression events per sucking burst.
Unknown
February 7, 2017
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